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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K220813
Device Name ART-PLAN
Applicant
TheraPanacea
Pépinière Cochin Paris Santé, 29 rue du Faubourg
Saint-Jacques
Paris,  FR 75014
Applicant Contact Edwin Lindsay
Correspondent
TheraPanacea
Pépinière Cochin Paris Santé, 29 rue du Faubourg
Saint-Jacques
Paris,  FR 75014
Correspondent Contact Edwin Lindsay
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Codes
LLZ   MUJ  
Date Received03/21/2022
Decision Date 06/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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